The Ministry of Health's business unit Medsafe is responsible for administering the Medicines Act 1981 and Regulations 1984 and parts of the Misuse of Drugs Act 1975 and Regulations 1977. It regulates all therapeutic products and its aim is to meet acceptable standards of quality, efficacy and safety through pre-marketing approval and post marketing surveillance. The pre-marketing approval process involves:

Medicines are broken down into three categories: low, medium or high risk. Risk here is broader than our normal definition relating to the outcome of the exposure to a hazard (in this case a medicine); it also relates to the unknown. These categories are generally self explanatory, but, for example, all medicines containing a new chemical or biotechnological entity are classified as high risk, generic products that do not contain biological or biotechnological compounds medium risk, and over-the-counter or general sales medicines low risk. The evaluation process is different for high risk medicines. Such product applications are reviewed by the Medicines Assessment Advisory Committee.

The other product categories are assessed by the staff of Medsafe. For further information visit the Medsafe website - www.medsafe.govt.nz.